VS3 Medical has announced that the US Food and Drug Administration (FDA) has granted a Breakthrough Device designation to its VS3 system. According to the company, this designation is based on evidence demonstrating that the system has the potential to resolve debilitating pulsatile tinnitus caused by venous sinus stenosis.
“We believe the FDA’s recognition of pulsatile tinnitus as a debilitating condition is another positive step towards more timely diagnosis and appropriate treatment pathways for patients,” said VS3 founder Matthew Amans (University of California San Francisco [UCSF], San Francisco, USA). “Advances in imaging have significantly improved our understanding of the intracranial venous anatomy, enabling the development of technologies like ours that are designed to specifically address the underlying anatomical causes of symptomatic venous sinus stenosis.”
The investigational VS3 system was designed to specifically address the unique properties of the venous anatomy and stenoses. The self-expanding VS3 stent is engineered to conform to the venous sinus, and provide sufficient radial force to open intrinsic and extrinsic stenoses, the company states in a press release, also noting that the device is delivered using a dedicated stent delivery system designed to smoothly navigate the venous sinus anatomy and accurately position the stent upon deployment.
“The FDA’s recognition of the VS3 system as a Breakthrough Device is an important milestone for the VS3 team,” added Thomas Wilder, VS3’s chief executive officer (CEO). “We look forward to collaborating with the agency as we continue to generate evidence supporting the safety, effectiveness and clinical value of the system for this important patient population.”
